GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.
Palliative Care, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
About this trial
This is an interventional supportive care trial for Palliative Care focused on measuring Palliative care, Diabetes, Cancer, Advanced cancer, End Stage Cancer, Terminal Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged > or = 18 years
- Diagnosed with advanced oncological disease
- Known/newly diagnosed DM according to ADA criteria
- Need of a Insulin therapy and need of Glycemia Monitoring with at least three finger pricks/die
- Karnofsky Index >= 30
- Provision of signed and dated informed consent form
Exclusion criteria:
- Diagnosis of all types of Dementia
- Presence of severe psychiatric diseases/symptoms
- Kidney failure requiring dialysis
- Patients with implanted pacemaker
Sites / Locations
- Palliative care Service - Sheba Medical Centre
- Antea Foundation
- Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
- Unità Operativa Complessa di Oncologia Medica - Policlinico Univeristario Campus Bio-medico di Roma
- Fondazione FARO
- Hospiz im Park
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Continuous Glucose Monitoring
Standard Care
The FreeStyle Libre 2 Flash Glucose Monitoring System (FSL2) is a CGM device with real time alarms capability indicated for the management of diabetes in persons aged 4 and older. The Sensor holds eight (8) hours of data at a time. In order to have a daily diary of the Glucose level the patients or family or HCP must read the sensor (with reader or app) at least every height (8) hours. Every day at least three (3) scans of the sensor should be performed using the reader or the Smartphone App, generally at wake up in the morning, in the afternoon and at the time to go to sleep. The alarm system will be activated, so that the Glucose level is over the cut off limit of 180 mmol/L or when it is lower than the cut-off limit of 80 mmol/L, the patient and/or the family members and/or the caregiver will check the Glucose level by scanning the reader/smartphone over the sensor.
This arm will perform the usual standard routine for blood glucose monitoring in patients with insulin therapy, that is represented by at least three finger pricks/die according to the usual standards routine of each center. Different frequency of finger pricks glucose measurements could be performed on the basis of health care professional patient assessment of each patient's needs.